Out-of-Control FDA

The U.S. Food and Drug Administration (FDA) is out of control. Beyond the typical FDA reforms of getting drugs to patients faster, the FDA should reform its scare-tactic policies.

On a recent trip to California, The Heartland Institute’s Amanda Evans took a picture of a popular sign demonizing acrylamide (right), a chemical commonly found in food and drinks after heating or cooking.

Like so many government agencies, the FDA is missing the big picture: everything can be toxic at a high dose. Water. The Sun. Chocolate. We must remember the FDA, EPA, and other agencies uses higher than normal exposure doses of chemicals on rats to determine toxicity to humans. A detailed explanation of this by the University of California at Berkeley is here.

As corporate relations manager, Rachel Rivest Dunbar is the main liaison between The Heartland Institute and its more than 60 corporate supporters.
Before joining Heartland in May 2010 as development assistant, Dunbar was the annual giving coordinator for Shimer College in Chicago, Illinois, and a supervisor for Michigan State University’s Telemarketing Program in East Lansing, Michigan. She received her B.A. degree in chemistry from Michigan State University and conducted medicinal chemistry research under Dr. Rawle Hollingsworth, Afid Therapeutics, Inc. during her senior year.

Miss Dunbar, as an expert food toxicology consultant for 25 years on the California Proposition 65 warning law, I want to alert you that our federal FDA has nothing to do with this cancer warning sign appearing in retail coffee shops throughout California. In fact, FDA is explicitly not permitted to have any say on the workings of this California-only law and its regulations as they relate to foods, beverages or cosmetics. Federal law does not require such a cancer warning on brewed coffee products, in spite of the agency taking a very proactive approach over the past 10 years on research and guidance on the unavoidable presence of trace levels of acrylamide in about 40% of the foods we consume.

While acrylamide is present at very low parts-per-billion levels (10 ppb or less) in brewed coffee due to the heat from roasting, coffee drinking has been shown over the past 30 years to actually REDUCE the risk of many forms of human cancer because the whole coffee product contains numerous health- beneficial constituents. The Proposition 65 law allows a focus on this single chemical acrylamide in coffee, and because of overly conservative risk assessment techniques applied to the results of massive-dose animal testing (as you correctly point out), the law requires this warning be given, in spite of the fact that it is wholly unwarranted by the science.